U.S. Food and Drug Administration has approved Xtandi (enzalutamide) to treat men suffering from late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”
Formation of prostate cancer occurs in the male reproductive system in front of rectum and below bladder. Testosterone which is a male sex hormone facilitates the growth of tumor. It is estimated that in year 2012, 241,740 patients will suffer from prostate cancer and 28,170 patients will die as indicated by National Institute of Health.
The safety and effectiveness of Xtandi was determined during the clinical trials conducting on 1,199 patients suffering from metastatic castration-resistant prostate cancer who were initially treated with docetaxel. “The study was designed to measure overall survival (the length of time before death) in men receiving Xtandi compared with men receiving a placebo (sugar pill). The median overall survival for patients receiving Xtandi was 18.4 months, compared with 13.6 months for the patients who received placebo.”
Patients taking Xtandi may suffer some common side effects such as muscle pain, diarrhea, back pain, muscular weakness, difficulty sleeping, lower respiratory infections, blood in urine, tingling sensation, anxiety, and high blood pressure, tissue swelling, upper respiratory tract infections, fatigue, dizziness and etc.
One percent of patients taking Xtandi can also suffer seizures. So it is better to discontinue the therapy in such patients.
Marketing of Xtandi will be done by Astellas Pharma U.S., Inc. of Northbrook, IL and Medivation, Inc. of San Francisco, CA.
Source: FDA Consumer Update
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